The Medical Device Authority (MDA) has officially postponed the mandatory enforcement of the Medical Device Import Permit to July 1, 2027. This update provides manufacturers and importers with an extended transition period to adapt to the new ePermit system.
MDA, 31 DECEMBER 2025 – In a significant regulatory update, the Medical Device Authority (MDA) of Malaysia has announced a delay in the full enforcement of the Medical Device Import Permit requirements. Originally scheduled for January 2026, the mandatory compliance date has been pushed back by 18 months, offering stakeholders crucial extra time to align their logistics and regulatory strategies. Here is a breakdown of the new timeline, procedural changes, and strategic steps for manufacturers.
THE CORE UPDATE: ENFORCEMENT DELAYED TO 2027
The MDA has confirmed that the strict enforcement of the Medical Device Import Permit, initially set for January 2, 2026, will now take effect on July 1, 2027. Until this new enforcement date, the importation of medical devices will continue to follow existing customs declaration procedures. This delay is intended to facilitate a smoother transition for the industry, allowing sufficient time for system familiarization and user registration.
KEY MILESTONES IN THE NEW TIMELINE
The MDA has outlined a phased approach to implementation, ensuring that the industry can adapt gradually rather than facing an abrupt cliff-edge deadline.
- April 14, 2025 – System Go-Live: The transition period officially begins with the launch of the new ePermit system.
- June 1, 2026 – Voluntary Verification: Stakeholders can start voluntarily submitting Verification Slip applications for non-medical devices that fall under medical device tariff codes.
- July 1, 2027 – Mandatory Phase: Full enforcement enters into force. All medical device imports will strictly require the new permit.
PROCEDURAL CHANGES: THE SHIFT TO EPERMIT
The new framework moves away from manual processes to a fully digital environment.
- Platform: All applications must be submitted via the online ePermit system.
- Submission Window: Applications must be submitted at least 7 days prior to the shipment of devices.
- Processing Times:
- Standard: processed within 3 working days upon payment.
- Expedited: Urgent shipments (e.g., temperature-sensitive goods or overnight road transport) can be processed within 24 hours.
- Standard: processed within 3 working days upon payment.
FEES AND FINANCIAL INCENTIVES
To encourage early adoption during the transition period, the MDA is offering financial incentives:
- Fee Waiver: Importers are eligible for a processing fee waiver of up to RM130 during the transition phase.
- Standard Fees (Post-Waiver):
- Import Permit: RM130 per application.
- Verification Slip: RM50 per application.
- Import Permit: RM130 per application.
Note: While processing fees may be waived initially, registration and annual subscription fees for the ePermit system may still apply.
STRATEGIC ACTIONS FOR MANUFACTURERS
With the “System Design & Development” phase concluding in March 2025, manufacturers and importers should utilize this extended timeline effectively:
- Register Early: Complete the registration of “Super Users” and “Sub-Users” in the ePermit system immediately.
- Test the System: Take advantage of the voluntary period starting June 2026 to familiarize your logistics team with the application forms without the risk of shipment delays.
- Monitor Updates: The MDA will be conducting industry awareness sessions and hands-on training. Keep a close watch on the MDA portal for the schedule.
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